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syngo® Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting.

As a Cardiology PACS and information system, syngo® Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other departments.

syngo® Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S.

The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on. The hardware itself is not considered a medical device and not in the scope of this 510(k) submission.

syngo® Dynamics is a system that includes a DICOM Server which receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound, computer tomography, magnetic resonance and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.

syngo® Dynamics Version VA10A provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine), vascular ultrasound, including specific echo and cath lab oriented features for documentation support in the cardiology department.

The provided 510(k) summary for syngo® Dynamics (Version VA10A) does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in a quantitative sense with performance metrics like sensitivity, specificity, or accuracy.

The document states:
"Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device."

However, it does not provide the specific acceptance criteria or the reported device performance metrics against those criteria. Instead, the focus of this 510(k) summary is on demonstrating substantial equivalence to a predicate device (syngo® Dynamics Version 9.0 (K102150)) based mainly on functional equivalence, technological characteristics, and risk management.

Here's a breakdown of the information that is available in the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission focuses on functional equivalence rather than quantitative performance metrics for a specific clinical task.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly stated for any performance testing. The document mentions "Integration and System Testing were performed for verification and validation of The device," but does not specify the sample size of images, cases, or the origin (country, retrospective/prospective) of any data used for these tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not provided. Since no specific clinical performance study with annotated ground truth for a diagnostic task is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Without a specific clinical performance study and expert-established ground truth, adjudication methods are not discussed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The device, a PACS system, is not typically evaluated in this manner, as it's an infrastructure tool rather than a diagnostic algorithm that directly aids human readers in interpretation beyond displaying images. The submission focuses on its capabilities as an image and information system.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm is mentioned. This device is described as a "software only" medical device, but its function is as an image and information system (PACS), not a standalone diagnostic algorithm with a specific output to be evaluated for accuracy.

7. Type of Ground Truth Used

Not applicable/Not provided in relation to a clinical performance study. The ground truth concept for this device's validation would likely revolve around functional correctness, data integrity, and adherence to standards (DICOM, HL7, etc.), rather than clinical diagnostic accuracy against pathology or outcomes data.

8. Sample Size for the Training Set

Not applicable/Not provided. As this is a PACS system and not a machine learning-based diagnostic algorithm, there isn't a "training set" in the sense of data used to train an AI model. Its development would involve software engineering and testing principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided for the same reasons as #8.

In summary, the 510(k) for syngo® Dynamics (Version VA10A) focuses on establishing substantial equivalence through:

• Identical Intended Use: The device shares the same intended use as its predicate.
• Similar Technological Characteristics: The document provides a detailed table comparing functionalities, operating systems, image sources, display, data handling, and algorithms with the predicate device, highlighting minor enhancements (e.g., collaborative reporting, mobile device support) that do not raise new safety or effectiveness concerns.
• Compliance with Voluntary Standards: DICOM, IEC/ISO, HL7, IEC 62366, SMPTE are listed.
• Risk Management: Adherence to ISO 14971:2007 for risk analysis and control.
• Verification and Validation Testing: General mention of "Integration and System Testing" to verify design output against input and validate conformance to intended use.

The submission confirms that "Predefined acceptance criteria was met" for these tests, but it does not specify what those criteria were in the context of clinical performance metrics, nor does it provide quantitative results from such a study. The nature of a PACS system's 510(k) often centers on functional validation and interoperability rather than diagnostic accuracy as would be required for an AI-powered diagnostic tool.

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